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Views: 58 Author: Unibest Industrial Publish Time: 2024-08-01 Origin: Site
Deucravacitinib has emerged as a groundbreaking treatment for moderate-to-severe plaque psoriasis. As we at Unibest keep up with the current pharamceutical blockbusters, we're excited to explore the potential of this novel drug in the enormous oral systemic psoriasis drug market.
Deucravacitinib, marketed under the brand name SotyktuTM, made history in September 2022 as the first de novo deuterated drug approved by the FDA. This achievement marks a significant milestone in drug development, opening new avenues for enhancing drug properties through deuteration.
What sets deucravacitinib apart is its mechanism of action. As the first-in-class TYK2 negative allosteric inhibitor, it represents a novel approach to treating psoriasis. This unique mode of action could pave the way for a new generation of treatments for autoimmune disorders.
The swift approval of Sotyktu by both the FDA and the European Commission (EC) underscores the drug's potential:
- FDA approval: September 2022
- EC approval: March 2023
Sotyktu's approval was based on robust clinical data from Phase III POETYK PSO-1 and POETYK PSO-2 trials, as well as additional data from POETYK PSO long-term extension trial.
Recent results from the POETYK PSO LTE trial showed maintained clinical response rates, with 73.2% of patients achieving PASI 75 after three years of continuous treatment. Importantly, Sotyktu demonstrated a consistent safety profile with no new safety signals.
This rapid global acceptance indicates a high unmet need in psoriasis treatment and suggests a potentially lucrative market for similar products.
Psoriasis represents a significant global health burden. According to the GDB 2021 study, there were over 4.6 million incident cases worldwide, and the age-standardized incidence rate was 57.8 per 100,000 people. Psoriasis also showed a higher incidence rates in high-income countries (112.6 per 100,000).
Based on the Joint American Academy of Dermatology-National Psoriasis Foundation guidelines of care for the management of psoriasis with systemic nonbiologic therapies, oral systemics for psoriasis treatment are almost all generic drugs including methotrexate, cyclosporine, acitretin, and apremilast. Among them, methotrexate, cyclosporine and apremilast are all immunosuppressant, the same category as deucravacitinib, and only methotrexate and apremilast are beneficial for long-term uses.
Using methotrexate, a main oral systemic drug for psoriasis (chosen by 86% of patients who took oral systemics), as the benchmark for market estimation, the oral systemic drug market for psoriasis is estimated to be around 25.7 billion USD.
Moreover, psoriatic arthritis is often underdiagnosed, with 10.9% to 29.0% of psoriasis patients in European countries having undiagnosed psoriatic arthritis. This suggests that the true market potential for psoriasis treatments may be even larger than current estimates.
How has the market performance of SotyktuTM been?
Since its launch in September 2022, SotyktuTM has generated 274 million USD for BMS. In FY 2023 alone, the revenue reached 170 million USD, which accounted for approximately 4.44 Kg of Deucravacitinib API demand and 0.66% of the 25.7 billion USD psoriasis oral systemics drug market. If worldwide psoriasis patients using oral systemics were to use SotyktuTM as the only monotherapy and stick to long-term treatment, the theoretical deucravacitinib API demand ceiling is 102,933 Kg. With BMS's ongoing clinical trials of Deucravacitinib for Alopecia Areata, Discord Lupus Erythematosus, Psoriatic Arthritis, Systemic Lupus Erythematosus, and Sjögren's Syndrome, as well as post-market penetration, the Deucravacitinib API demand is expected to grow.
